Chronic Myeloid Leukemia

• FDA label_change · 2024-12-03
  FDA Approved: BOSULIF — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for BOSULIF (bosutinib) from Pfizer, updating the drug’s labeling. This indicates a change to th…

• FDA label_change · 2023-11-08
  FDA Approved: SCEMBLIX — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for SCEMBLIX (asciminib) submitted by Novartis Pharmaceuticals Corporation. The action involves chan…

• FDA label_change · 2020-06-17
  FDA Approved: BOSULIF — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for BOSULIF (bosutinib) filed by Pfizer, resulting in updated labeling for the drug.

• FDA label_change · 2018-03-22
  FDA Approved: TASIGNA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for TASIGNA (nilotinib) from Novartis to update the drug's label.

• FDA label_change · 2016-08-31
  FDA Approved: ICLUSIG — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for ICLUSIG (ponatinib hydrochloride) by Takeda Pharmaceuticals America, Inc., resulting in labe…

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• FDA label_change · 2016-06-02
  FDA Approved: ICLUSIG — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for ICLUSIG (ponatinib hydrochloride) from Takeda Pharmaceuticals America, Inc. The approval updates…

• FDA label_change · 2016-04-04
  FDA Approved: BOSULIF — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for Bosulif (bosutinib) submitted by Pfizer Laboratories Div Pfizer Inc.

• FDA label_change · 2014-08-15
  FDA Approved: ICLUSIG — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application to update the labeling for ICLUSIG (ponatinib hydrochloride) from Takeda Pharmaceuticals America, In…

• FDA label_change · 2013-12-20
  FDA Approved: ICLUSIG — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for ICLUSIG (ponatinib hydrochloride) from Takeda Pharmaceuticals America, updating the labeling for…

• FDA label_change · 2013-09-27
  FDA Approved: TASIGNA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Tasigna (nilotinib) from Novartis, outlining changes to the drug’s labeling.

• FDA label_change · 2012-01-26
  FDA Approved: DROXIA — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for DROXIA (hydroxyurea) from Waylis Therapeutics LLC, indicating a label change/expansion. The docu…

• FDA label_change · 2011-11-18
  FDA Approved: TASIGNA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for TASIGNA (nilotinib) from Novartis Pharmaceuticals Corporation, resulting in changes to the drug'…